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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03370146
Other study ID # L3020
Secondary ID
Status Recruiting
Phase N/A
First received November 29, 2017
Last updated December 12, 2017
Start date March 17, 2015
Est. completion date October 30, 2018

Study information

Verified date December 2017
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- Right handed

- No contraindication to the fMRI exam

Exclusion Criteria:

- Contraindication to the fMRI exam

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mental training based on Motor Imagery
Patients of the experimental group will be instructed to imagine walking, from a first person perspective, focusing on the kinaesthetic sensations typically associated with the movement. The motor imagery training will be performed using the support of a laptop, on which there will be presented complex static scenes, representing different kind of paths with different landmarks to reach during the mental walking.
Cognitive training
Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.
Evaluation of gait abilities
All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities

Locations

Country Name City State
Italy IRCCS Galeazzi Orthopedic Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speed of walking The speed of walking recorded in total knee arthroplasty patients of the experimental group will be compared with the same measure recorded in both control groups. 20 days
Primary BOLD (blood oxygen level-dependent) activity The BOLD activity recorded during functional magnetic resonance imaging (fMRI) in TKA patients of the experimental group will be compared with the same measure recorded in both control groups. 20 days
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